BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS

    K Number: K092244 · Decision Mar 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    234
    Applicant Total
    1
    Review Days
    216

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    Basic Information

    Device Name
    MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
    K Number
    K092244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1050
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Group, LLC
    Date Received
    July 28, 2009
    Decision Date
    March 1, 2010
    Product Code
    EWO
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EWO Audiometer

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